Kornimate/medical-research-clean huggingface dataset:
investigate the safety and tolerability of azd6244 monotherapy or + docetaxel in japanese patients with advanced solid malignancies or non-small cell lung cancer

Conditions: Neoplasms,; Metastatic Cancer,; Non-Small Cell Lung Cancer; Advanced Solid Malignancies

Summary: the objective of this study will be to investigate the safety and tolerability of azd6244 given monotherapy or in combination with docetaxel as 2nd line therapy in japanese patients with advanced solid malignancies or locally advanced or metastatic non-small cell lung cancer. in addition, the pharmacokinetic profile of azd6244 will be investigated. following the combination regimen dose escalation phase (part a) of the study additional patients may be enrolled to a dose expansion phase (part b) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

the objective of the combination therapy part of this study will be to investigate the safety and tolerability of azd6244 given in combination with docetaxel as 2nd line therapy in japanese patients with locally advanced or metastatic non-small cell lung cancer (stage iiib-iv). in addition, the pharmacokinetic profile of azd6244 and docetaxel will be investigated. the objective of the monotherapy part of this study will be to investigate the safety and tolerability of azd6244 given as a monotherapy in japanese patients with advanced solid malignancies. in addition, the pharmacokinetic profile of monotherapy azd6244 will be investigated.

Eligibility criteria:
inclusion criteria: * patients diagnosed with lung cancer who have not responded to prior therapy or have become worse. * patients who have overall good general conditions. * patients who have at least one lesion that can be accurately assessed by imaging. * patients who have appropriate renal conditions confirmed by test results for taking part in the study. * evidence of non-childbearing status for women of childbearing potential, or postmenopausal status. exclusion criteria: * patients with brain metastases or spinal cord compression. * patients with significant abnormal ecg findings. * patients with evidence of severe or uncontrolled systemic disease. * the main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards. * patients with known hypersensitivity to docetaxel or products containing polysorbate 80. only for monotherapy cohort eligibility criteria patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment. patients with histologically or cytologically confirmed advanced solid malignancies.

Keywords: cancer, tumour, metastatic, lung cancer, non-small cell lung cancer
post-market study of multi-vector left ventricular lead performance in chinese patients with chronic heart failure

Conditions: Chronic Heart Failure

Summary: the purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (lv) lead in chinese patients that are indicated for cardiac resynchronization therapy (crt).

this is a multi-center, non-randomized observational study. the total duration of the study is expected to be 2.5 years. the clinical study will be conducted in no more than 15 centers in china. approximately 120 subjects will be enrolled in this study. subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. all subjects need to be followed for at least 6 months.

Eligibility criteria:
inclusion criteria: * meets the current european society of cardiology (esc) or american college of cardiology foundation (accf)/american heart association (aha)/heart rhythm society (hrs) class i or class iia indications for crt implant (including upgrades from single or dual chamber implantable cardioverter-defibrillators (icds)) * are ≥ 18 years of age at the time of enrolment. * are able to provide written informed consent prior to any study related procedure. exclusion criteria: * patient who is unable to comply with the follow-up schedule. * patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study . * patient has a life expectancy of less than 1 year due to any condition. * patients, who has a crt device implanted
phase 1/2 study of enzastaurin in newly diagnosed glioblastoma multiforme (gbm) and gliosarcoma (gs) patients

Conditions: Glioblastoma; Glioblastoma Multiforme; Gliosarcoma

Summary: there will be 2 phases in this study. patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study. the first phase of this study is done to evaluate the safety of enzastaurin in patients. this is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects. in the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.


Eligibility criteria:
inclusion criteria: * patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (gbm) or gliosarcoma (gs). * biopsy or resection must have been performed no more than 5 weeks prior to treatment. * an mri or ct scan must be obtained within 14 days prior to treatment. * patients must not have received prior drug therapy for brain tumors. * patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment. exclusion criteria: * patients will be excluded if unable to swallow tablets. * patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (dilantin®), carbamazepine, etc.). * patients will be excluded if have active infection. * patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy. * patients will be excluded if they have concurrent therapy with an anticoagulant. if the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.
bladder cancer screening among diabetic patients

Conditions: Bladder Cancer; Diabetes

Summary: patients om metformin from diabetic clinic were checked for bladder cancer


Eligibility criteria:
inclusion criteria: * 150 people attending diabetic clinic exclusion criteria:

Keywords: pathology
risk factors of incidence of type 2 diabetes and cardiovascular diseases---shanghai baoshan study

Conditions: Type 2 Diabetes; Cardiovascular Disease

Summary: objective: recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose metabolism, impaired glucose regulation (igr), and with type 2 diabetes. to study the risk factors in development of type 2 diabetes.

methods: we aim to perform a two-step blood glucose survey in 2008-2009 in a population selected from a single urban community of shanghai. the institutional review board of the rui-jin hospital approved the study protocol. informed consent will be obtained from each participant. 1. in the first step, we first invited all registered permanent residents aged 40 or above by local poster advertisement and by mail to participate in a screening examination, during which we collected information on lifestyle, medical history and the use of medications using a questionnaire, and performed anthropometrical measurements and fasting glucose measurement. the first step of diabetes screening finished in june, 2008. 2. in the second step, after exclusion of subjects with self-reported diabetes, we classified the screened subjects into 3 groups according to their fasting plasma glucose concentration of 7.0 mmol/l or above, 5.0 to 6.9 mmol/l or below 5.0 mmol/l. we selected randomly a sample from these 3 subgroups for further investigation including a 75-g oral glucose tolerance test (ogtt) and blood and urine sampling and other vascular functional measurements. our selection was based on a ratio of 1:1.2:1.44, because of the concern that by knowing the results of fasting plasma glucose test, subjects with lower glucose levels might have a lower participation rate than those with higher glucose concentrations. nevertheless, this ratio was arbitrarily chosen. finally, 1000 type 2 diabetic patients, 1200 subjects with igr and 1440 subjects with normal glucose metabolism were selected as target population of this study by random sampling for further blood and urine sampling. 3. biomarkers and genetic risk factors will be evaluated in the study subjects.

Eligibility criteria:
inclusion criteria: * aged above 40 years exclusion criteria:

Keywords: genetic
motivational interviews for incarcerated teens - 1

Conditions: Alcoholic Intoxication; Marijuana Abuse

Summary: the purpose of this study is to test the efficacy of an individual motivational interview for reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in incarcerated teens.

the objective of this research is to investigate ways to enhance motivation for treatment and effectively reduce substance abuse among juvenile offenders. motivational intervention (mi) as preparation for residential treatment and for persons (including teens) with little motivation to change has been effective in reducing substance abuse. thus, mi designed for delinquent youths who are required to attend substance abuse treatment may prove efficacious. in this proposed randomized trial, a one-way design (mi + standard care \[sc\] v. attention control \[ac\] + sc) will be used to determine whether mi enhances subsequent treatment participation and reduces substance-related problems post discharge in substance using, delinquent youths. teens will also receive a booster session of mi or ac prior to discharge. primary outcome variables include alcohol and marijuana use, as well as related behaviors (illegal activity, sex or injuries while drunk or high). it is hypothesized that in comparison to teens receiving ac, youths receiving mi will participate more (by therapist and teen ratings) in sc and will show the lowest levels of heavy substance use and related problems after discharge. it is hypothesized that these effects will be mediated by stage of change, drug effect expectancies and self-efficacy. this study will extend previous research by evaluating the use of mi with substance abusing teens in a correctional facility, and by expanding outcome measures to include alcohol and marijuana-related risk behavior (such as injuries and illegal activity when drunk or high) in this population. the development of effective interventions for substance using juvenile offenders has the potential to reduce substance abuse and crime in this population.

Eligibility criteria:
inclusion criteria: teens will be included if they meet any of the following criteria: 1) in the year prior to incarceration they used marijuana regularly (at least monthly); 2) in the year prior to incarceration they drank regularly (at least monthly) or binged (\>=5 for boys; \>=4 for girls) over any two week period or less; 3) they used marijuana or drank in the 4 weeks before the offense for which they were incarcerated; or 4) they used marijuana or drank in the 4 weeks before they were incarcerated. exclusion criteria: those teens sentenced for less than 4 months or greater than 12 months will be excluded from participation. we estimate that during year 1 we will exclude an additional 25% of youths because they will have previously participated in the study, and at year 2 we anticipate excluding an additional 49% of youths based on prior participation in the study.

Keywords: alcohol, marijuana
efficacy of end-of-life communication strategies on nurses in the intensive care unit

Conditions: Palliative Care

Summary: burnout among healthcare workers is frequently reported, and one of the factors cited is the stress caused by end-of-life care. it has been reported that nursing staff experience decreased well-being as a result of being involved in end-of-life care, and this is also true in intensive care units. this decrease in well-being is said to lead to lower quality of care, poor communication with patients and their families, absenteeism, and high turnover. although palliative care interventions such as education and communication tools have been reported to improve the well-being of healthcare professionals involved in end-of-life care, few reports have evaluated the association with burnout. we investigated whether communication-based palliative interventions in end-of-life care in intensive care units (icus) improve the risk of burnout among nurses working in icus.

a before-and-after study was conducted in a single hospital to evaluate burnout risk and satisfaction with end-of-life situations in 2022 (phase 1) and 2023 (phase 2). the japanese version of the burnout scale was used to assess the risk of burnout, and the qodd (quality of dying and death) was used to assess nurse satisfaction. all nurses who agreed to participate received the questionnaire in a sealed envelope, completed it, and returned it anonymously to the principal investigator. data from those who declined to participate were not recorded. during the first and second phases, an intensive communication strategy on end-of-life practice was implemented based on the framework developed at the international delphi conference. the following data were recorded for all participating nurses: age, gender, marital status, years of practice since certification, and years of critical care experience; the following data on icu status were also collected from the electronic system: total number of patients, length of icu stay, icu mortality rate, in-hospital mortality rate, icu admission apache-ii score, sofa score at icu admission, and medical costs at icu admission. continuous variables without normal distribution are shown as median and interquartile range. categorical data were summarized numerically or as percentages. in univariate analyses, mann-whitney's u test was used to compare continuous variables and fisher's exact test to compare categorical variables. data were assumed to be missing at random, and no imputation or interpolation of missing values was performed. statistical tests were two-tailed and statistical significance was set at p\<0.05. all statistical analyses were performed using ezr (r foundation for statistical computing, vienna, austria), a graphical user interface for r. the study was approved by the maebashi red cross hospital ethics committee (id: 2022-47), which waived the requirement for informed consent from patients and their relatives, given the retrospective and observational nature of the study.

Eligibility criteria:
inclusion criteria: * registered nurses working in our icu exclusion criteria: * none
a ccafu-uroccr randomized trial: 3d image-guided robot-assisted partial nephrectomy for renal complex tumor (uroccr n°99)

Conditions: Renal Tumor; Renal Cancer

Summary: the goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3d igrapn compared to conventional robot-assisted partial nephrectomy (rapn) for moderate and highly complex renal tumors. the main questions aim to answer: * peri-operative complications * oncological safety * long term renal function participants will be asked to do undergo 3d-igrapn. researchers will compare 3d-igrapn to rapn to see if peri-operative outcomes are better in the experimental group.

robot-assisted partial nephrectomy (rapn) is the standard treatment for localized kidney tumors. new 3d modeling and reconstruction technologies have enabled the development of real time imageguided surgery using virtual reality (vr). in view of advances in artificial intelligence and surface recognition based on deep-learning, augmented reality (ar) by merging a 3d reconstructed virtual image onto the real per-operative view represents the next step in image-guided surgery. 3d ig-rapn using synapse 3d (fujifilm) and davinci tile-pro display (intuitive surgical) vs conventional rapn without 3d navigation in 12 high-volume urological centers from the uroccr network. outcoume : primary endpoint is a composite validated score (trifecta) evaluating peri-operative complications as well as oncological safety and long-term renal function preservation. secondary endpoints assess long-term survival, ergonomics and surgeon satisfaction. a medico-economic evaluation will be performed. methodology: accurate is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling 694 patients with a single complex renal mass, defined as renal ns≥7. randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.

Eligibility criteria:
inclusion criteria: * patients over 18 years * indication of rapn for suspicious renal tumor * moderate or high complexity renal tumor (renal nephrometry score (ns) \>7) * da vinci® surgical system available for the surgery * patient affiliated to the french social security system or an equivalent system * signed informed consent form uroccr and accurate exclusion criteria: * medical contraindication to rapn * renal insufficiency forbidding iodine injection * patient with allergy to iodinated contrast products * patient concerned by articles l1121-5 to 8 of the french public health code (protected persons)

Keywords: image guidance augmented reality robotics
evaluation on efficacy of total artificial disc replacement (tdr) of cervical spondylosis

Conditions: Cervical Spondylosis

Summary: to evaluate the efficacy of 3 different types of cervical disc prosthesis (prodisc-c, mobi-c and prestige-lp) in the treatment of cervical spondylosis.

a cohort, retrospective analysis will be performed of 150 patients who were in implementation of artificial disc replacement in our department from 2008 to 2012 and accepted a regular postoperatively follow-up up to 5 years, the sample will be divided into 3 groups according to prosthesis and 50 people in each group. the outcome will be measured among 3 groups respectively on the operation (such as operation time, intraoperative bleeding.), postoperative complications (such as prosthesis sinking, displacement and prolapse, adjacent segments degeneration and heterotopic ossification), photographic indicators and functional efficacy analysis and then a comparison for self-contrast pre- and post-operatively.

Eligibility criteria:
inclusion criteria: 1. patients was diagnosed as cervical spondylosis based on imaging and symptomology; 2. patients were purely underwent tdr within the three kinds of prosthesis; 3. the range of participants is from 20-65 years; 4. conservative treatment of 6 months is invalid; 5. never had cervical operations. exclusion criteria: 1. patients suffered from cervical trauma or congenital malformations; 2. non-artificial cervical disc replacement or hybrid surgery; 3. ones who refused to be followed up.

Keywords: cervical spondylosis artificial disc replacement complications photographic indicators functional efficacy
effects of tupler and scoop exercises in diastasis recti

Conditions: Diastasis

Summary: to compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis.


Eligibility criteria:
inclusion criteria: * bmi 25kg\|m\^2 to 30kg\\m\^2or greater * multiparous women * participants included will be 3 months post-partum females * caesarean delivery who will have with the presence of dra \>2 finger width and \>2cm exclusion criteria: * patients who had hernia * trauma to bowel or bladder * malignancies * neurologic disease and its associated balance disorders, * pelvic or abdominal surgery (except for a caesarean section) were considered as the exclusion criteria of this study

Keywords: diastasis recti abdominis low back pain muscle strength pilates-based exercises static stretching.
patent ductus arteriosus (pda) screening trial

Conditions: Ductus Arteriosus, Patent

Summary: the ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. in preterm infants the incidence of spontaneous closure decreases with gestational age. patent ductus arteriosus (pda) increases the risks of bronchopulmonary dysplasia (bpd) and necrotizing enterocolitis (nec). however, this association may not be a causal relationship. echocardiography is required to diagnose pda. however, routine screening echocardiograms lead to detection of asymptomatic pdas, for which the benefit of therapy remains unproven. a randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. the investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.


Eligibility criteria:
inclusion criteria: * birth weight less than or equal to 1250 grams * gestational age less than or equal to 30 weeks * postnatal age less than or equal to 72 hours * have a guardian or acceptable surrogate capable of giving consent on his/her behalf exclusion criteria: * not considered viable * dysmorphic features or congenital malformations that adversely affect growth * have known or suspected congenital heart disease (other than pda)

Keywords: echocardiography infant, premature infant, very low birth weight
a study of the safety and efficacy of a new treatment for macular edema resulting from retinal vein occlusion

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * 18 years of age or older with macular edema resulting from retinal vein occlusion * decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) * visual acuity in other eye no worse than 20/200 exclusion criteria: * known anticipated need for ocular surgery within next 12 months * history of glaucoma or current high eye pressure requiring more than 1 medication * diabetic retinopathy * uncontrolled systemic disease * known steroid-responder * use of systemic steroids * use of warfarin/heparin